K780222 - I.V. START KIT (FDA 510(k) Clearance)

K780222 is an FDA 510(k) clearance for the I.V. START KIT. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 28, 1978 after a review of 47 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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